MAUDE Adverse Event Report: BIOSENSE WEBSTER INC VIZIGO; INTRODUCER, CATHETER

Catalog Number	D138503
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a vizigo and when the catheter was inserted into the vizigo sheath, air entered from the three-way stopcock.Air entry was prevented by clamping the side port with forceps.The procedure was completed.No adverse patient consequence was reported.
Additional Manufacturer Narrative
The product was returned to johnson & johnson medtech (j&j medtech) for evaluation.Therefore, section d9 has been updated.It was reported that a patient underwent a cardiac ablation procedure with a vizigo and when the catheter was inserted into the vizigo sheath, air entered from the three-way stopcock.Device investigation details: visual and microscopical inspection and backpressure test of the returned device were performed in accordance with j&j medtech procedures.Visual analysis of the returned sample revealed that the three-way stopcock of the device was broken.Back pressure test was performed, and water leakage was observed coming through the broken three-way stopcock.This condition could be related to the issue reported, no other damage or anomalies were observed.A device history record was performed for the finished device batch number, and no internal actions were identified.Additionally, the manufactured date has been provided.Therefore, field h4.Device manufacture date has been populated.The issue reported by the customer was confirmed.The potential cause of the three-way stopcock broken condition could be related to the handling of the device during the procedure; however, this could not be conclusively determined.The instructions for use (ifu) contain the following information: before inserting the sheath into the patient, flush the sheath and dilator with heparinized normal saline to remove air bubbles and any potential particulate.After the sheath is in the left atrium of the patient, maintain a constant flow of heparinized normal saline to the sheath to minimize the risk of air emboli.Use best practices for inserting or retracting any device at the hemostatic valve.Monitor any potential air entrapped and completely aspirate any observed air out of the side port.Once the sheath is inserted into the vasculature and the dilator is removed, aspirate until steady blood return is achieved prior to flushing or infusion.All fluid infusion should be through the side port.In order to minimize the risk of air embolism provide a continuous infusion of heparinized saline solution once the sheath is inserted into the patient.Slowly remove or insert the dilator or other devices.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: VIZIGO
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): FREUDENBERG MEDICAL LLC; 2301 centennial blvd; jeffersonville IN 47130
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 24255484
• Report Number: 2029046-2026-00380
• Device Sequence Number: 12820472
• Product Code: DYB
• UDI-Device Identifier: 10846835016260
• UDI-Public: (01)10846835016260(17)270916(10)00003037
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: D138503
• Device Lot Number: 00003037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NRG RF TRANSSEPTAL NEEDLE, NRG-E-HF-89-CO-J.
• Patient Sex: Unknown